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    Summary
    EudraCT Number:2004-002437-39
    Sponsor's Protocol Code Number:SPI-103
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-002437-39
    A.3Full title of the trial
    A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan)Administered for 72 Hours by Continuous Intravenous Infusion in Subjects with Acute Ischemic Stroke and Measurable Penumbra on MRI.
    A.4.1Sponsor's protocol code numberSPI-103
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaiichi Asubio Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePiclozotan
    D.3.2Product code SUN N4057
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of acute stroke.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 in subjects with clinical findings of an acute ischemic stroke and an MRI demonstrating a measurable penumbra (perfusion-weighted imaging [PWI] minus diffusion-weighted imaging [DWI] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume between Screening and Day 28, with stroke lesion volume assessed by DWI at Screening and by FLAIR (fluid-attenuated inversion recovery) at Day 28, in the SUN N4057 group versus the placebo group.
    E.2.2Secondary objectives of the trial
    The study drug was administered for a period of 72 hours, and patients were followed up for 90 days.

    1. To compare the SUN N4057 group versus the placebo group for:
    - The absolute change in stroke lesion volume and percent change in stroke lesion volume between Screening to Day 28;
    - The clinical outcomes at Day 28 and 90 using the individual clinical scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale [NIHSS]);
    - The global test statistic (GTS) at Days 28 and 90 using the results on the Modified Rankin Scale, Barthel Index, and NIHSS;
    - All-cause-mortality at Day 28 and 90; and
    2. To assess the safety and tolerability of SUN N4057 in subjects with acute stroke.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    General Inclusion Criteria
    1. Males or females >= 18 and <= 85 years of age at randomization. Female subjects must be either:
    - Surgically sterile
    - Post-menopausal for at least 1 year
    - Non pregnant confirmed by serum pregnancy test, and using a method
    of birth control that is acceptable to the investigator.
    2. Neurological examination demonstrating localizing cortical signs
    3. Receipt of study drug less than 6 hours (50% of subjects) or between 6 and 9 hours, inclusive, (50% of subjects) after the onset of symptoms (for un-witnessed stroke, last time seen in normal state or at bedtime for un-witnessed stroke during sleep)
    4. Signed informed consent from subject or a legally acceptable representative
    5. NIHSS score of 6 - 22, inclusive, or at least 2 on the aphasia item of the NIHSS with a location of MRI findings consistent with aphasia

    MRI-Determined Inclusion Criteria
    1. Acute ischemic stroke with substantial cortical involvement in the middle cerebral
    artery (MCA) distribution, as verified by the Screening DWI abnormality and/or Screening PWI abnormality. (Note: white matter involvement, in addition to cortex, is not an exclusion.)
    2. DWI with the longest diameter in any plane of at least 2 cm and no longer than 8 cm
    3. PWI with the longest diameter in any plane of at least 3 cm
    4. Screening PWI abnormality exceeding the Screening DWI abnormality (mismatch) by 50% in volume or > 1 cm in diameter
    E.4Principal exclusion criteria
    General Exclusion Criteria:
    1. Two or more of the following:
    a. Reduced level of consciousness (score  2 on NIHSS Q1a)
    b. Forced eye deviation or total gaze paresis (score of 2 on NIHSS Q2)
    c. Dense hemiplegia (no movement) of upper and lower extremities (score of 4 on NIHSS Q5 regarding motor arm and a score of 4 on NIHSS Q6 regarding motor leg)
    2. Pre-stroke Modified Rankin score  2 at Screening
    3. Rapid neurological improvement from Screening up to the start of drug infusion
    4. Persistent systolic blood pressure (SBP) > 220 mmHg and/or diastolic blood pressure (DSP) > 120 mmHg (confirmed by at least three readings taken at least 3 minutes apart) prior to randomization. If subsequent readings are consistently below these levels, either spontaneously or following mild antihypertensive therapy, the subject may be enrolled.
    5. Aggressive anti-hypertensive therapy required to maintain blood pressure at acceptable levels
    6. Female subjects who are pregnant and/or nursing, confirmed by serum pregnancy test
    7. Administration of an investigational product within the past 30 days
    8. Currently taking any selective serotonin reuptake inhibitor (SSRI) and/or other medications listed in Section 9.9 and Attachment II of the protocol
    9. Significant renal dysfunction as defined by a serum creatinine > 2.5 mg/dL and a creatinine clearance < 30 mL/min based on Cockroft-Gault formula
    10. Significant hepatic disease as defined by liver function tests (LFT)  3 times the upper limit of normal
    11. Seizure during the current stroke episode
    12. Received, or is a candidate to receive, thrombolytics for the current stroke episode
    13. Life expectancy of less than 90 days
    14. Another significant neurologic disease or previous stroke in addition to the current stroke that would, in the opinion of the Investigator, interfere with the neurological assessment
    15. Myocardial infarction within 3 months of study entry
    16. Unstable angina pectoris
    17. Congestive heart failure with symptoms either at rest or minimal exertion (New York Heart Association [NYHA] Class III or IV)
    18. Cardiac conduction system abnormality including second or third degree atrioventricular (AV) block
    19. Sinus bradycardia (resting heart rate< 50 beats per minute) or a history of sick sinus syndrome
    20. Evidence of QTc prolongation (>450 milliseconds) on Screening ECG
    21. Known history of symptomatic orthostatic hypotension
    22. Persistent elevation of glucose > 300 mg/dL during screening
    23. Cancer under active treatment
    24. Received known cytochrome P450 3A4 inhibitors including azole antifungal agents (e.g., ketoconazole, itraconazole) within 24 hours prior to Hour 0 and for 3 days after Hour 72. An appropriate longer washout period is required for drugs with a longer half-life.

    MRI-Determined Exclusion Criteria
    1. Intracranial hemorrhage as verified by the Screening MRI (or a computerized tomography [CT] scan performed pre-screening)
    2. Subacute stroke in a symptomatic region of the brain verified by significant T2 shine through on the Screening FLAIR MRI
    3. Significant mass effect, edema, or midline shift including Screening DWI abnormality greater than 2/3 of the MCA territory
    4. DWI longest diameter greater than 8 cm or less than 2 cm
    5. No Screening PWI abnormality and therefore no PWI/DWI mismatch
    6. Contraindication to MRI (ferrous implants, cardiac pacemakers, claustrophobia, or known sensitivity to MRI contrast agents)
    7. Severe agitation that precludes MRI
    E.5 End points
    E.5.1Primary end point(s)
    Although the treatment period will last 72 hours, patients will be followed up for 90 Days. MRIs will be performed at Screening, Hour 12 of administration, and Day 28 of the study. Efficacy will be assessed by comparing the proportion of subjects who have no growth in stroke lesion volume as assessed by DWI on MRI at Screening to stroke lesion volume assessed by FLAIR on Day 28 (primary end-point).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Also sequential-group. Dose-escalation.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Date that all data clarifications have been completed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    When necessary, consent shall be obtained by a legal representative at inlcusion, and shall be requested from the subject once he or she is in a state to provide consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 206
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated according to current standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
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